Senior Manager, Development Quality

The Senior Manager, Development Quality serves as a senior technical and operational quality leader within the Development Quality function, providing expert oversight of CDMO/CMO quality activities and driving continuous improvement across development-stage radiopharmaceutical programs. This role leads the execution of quality management system processes - including deviation management, CAPA, change control, and batch record review - and functions as a primary quality interface with external manufacturing partners.

The Senior Manager brings deep radiopharmaceutical GMP expertise, exercises independent judgment on complex quality issues, and provides guidance and mentorship to junior quality team members. As the organization transitions from PET diagnostics into radiopharmaceutical therapeutics, this role plays a key part in building scalable quality processes and supporting IND-stage program needs across multiple country jurisdictions.

- Lead GMP compliance oversight for radiopharmaceutical development programs manufactured by CDMOs/CMOs, including real-time GMP monitoring, batch disposition support, and proactive identification of compliance risks specific to short half-life manufacturing environments.

- Own the preparation, review, and approval of key QMS documents within Telix PQS, and lead cross-functional process improvements to enhance the effectiveness and efficiency of the development-stage quality system.

- Provide senior-level guidance to manufacturing, project, and CMC teams on PQS requirements and quality expectations; serve as a subject matter expert on QMS processes for development-stage radiopharmaceutical

- Lead and independently execute batch release activities for investigational radiopharmaceutical products, including review and approval of batch records, QC results, and certificate of analysis documentation from CDMOs/CMOs.

- Provide senior review and approval of SOPs, batch records, QC results, and regulatory documents; independently assess compliance gaps and escalate risk-based recommendations to the Director, Development

- Demonstrate expert-level knowledge of radiopharmaceutical GMP requirements including PIC/S GMP, ICH guidelines, 21 CFR 210, 211, and 212, and USP <821>; provide interpretive guidance to teams and support regulatory submission quality inputs (IND/CTA Module 3).

- Lead the authoring, review, and approval of deviations, investigations, CAPAs, and change controls; mentor junior team members on investigation methodology, root cause analysis, and CAPA effectiveness evaluation to build team capability.

- Provide day-to-day guidance, mentorship, and technical oversight to junior Development Quality team members; contribute to onboarding, training development, and performance support within the

- Lead quality oversight of CDMO/CMO relationships, including conducting or co-leading supplier audits, managing audit observations through closure, and escalating systemic quality risks to the Director, Development Quality.

- Represent Development Quality in cross-functional program teams, providing independent quality voice in project governance, risk discussions, and regulatory readiness activities.

- BS/BSc or higher in a science-related discipline (e.g., Chemistry, Radiochemistry, Pharmacology, Biology, or related field) required; advanced degree (MS, PharmD) preferred.

- 8+ years of progressive quality experience within the pharmaceutical, biotechnology, or radiopharmaceutical industry, with demonstrated depth in development-stage GMP quality and CDMO/CMO oversight.

- Direct radiopharmaceutical quality experience required, including familiarity with short half-life manufacturing, USP <821>, real-time release testing, and hot-cell or dispensing operations quality oversight.

- Demonstrated expertise in independently authoring, reviewing, and approving SOPs, quality plans, and technical quality documents for development-stage programs.

- Extensive experience independently reviewing and approving batch records manufactured by CMOs/CDMOs, including radiopharmaceutical or sterile manufacturing batch records.

- Expert-level experience leading investigations, root cause analysis, and CAPA management; proven track record of independently authoring, reviewing, and approving complex deviations and change controls.

- Applied expertise in quality risk management using ICH Q9 frameworks; ability to independently conduct risk assessments and communicate risk-based recommendations to program teams and senior leadership.

- Demonstrated ability to operate as a senior quality representative in matrixed, cross-functional teams; experience influencing external vendor quality performance and driving issue resolution with CDMOs/CMOs.

- In-depth understanding of 21 CFR Part 210/211/212, ICH Guidelines (Q7, Q9, Q10), PIC/S GMP, and USP <821>; working knowledge of IND/CTA quality requirements and CTD Module 3 expectations for radiopharmaceutical development

- Radiopharmaceutical industry experience required; PET manufacturing or targeted radiotherapy development quality experience strongly preferred.

- Quality auditing experience required, including experience leading or co-leading GMP audits of external manufacturing partners; experience managing audit observations through closure preferred.

- Ability to travel (approximately up to 20%) for CDMO/CMO audits, site visits, and regulatory

- Experience mentoring or providing technical oversight to junior quality staff; formal people management experience is a plus but not required for this role.